MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO SPORT HINGED KNEE BRACE; ORTHOSIS, LIMB BRACE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Expiration date - this product has no shelf life, therefore no expiration date.This product is exempt from udi.Product lot # was not provided, therefore manufacture date is unknown.The device was not returned for evaluation.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales code of eab.Review of complaint history found no trends.End of report.

Event Description

A female customer (age unspecified) reported an incident regarding the futuro (tm) sport hinged knee.She purchased the product on (b)(6) 2021 and started wearing on the day.She wore the brace on her right knee from (b)(6) 2021 to (b)(6) 2021.On friday (b)(6) 2021, she allegedly noticed the area was bleeding, itchy, swollen and red.She applied hydrocortisone cream on the area but that did not resolve the alleged injury.She went to the doctor on monday.The doctor diagnosed the alleged injury as contact dermatitis.The doctor prescribed steroid cream for the alleged injury.She is allergic to latex.No medical history reported.

• Brand Name: FUTURO SPORT HINGED KNEE BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): WINNING INDUSTRIAL CO., LTD; hua nan industrial zone,; no. 10 jin-fu road; liaobu, dongguan guangdong 52340 5; CH 523405
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 12269765
• MDR Text Key: 264827460
• Report Number: 2110898-2021-00045
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 48579EN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention